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NCT04374435 · ClinicalTrials.gov registry record · NA
Evaluating the Efficacy of the Melanocyte Keratinocyte Transplantation Procedure in the Treatment of Vitiligo
A NA study, sponsored by University of California, Irvine.
- Terminated
- Registry status
- NA
- Development phase
- 17
- Enrollment target
NCT04374435 is a NA study that was terminated before completion, run by University of California, Irvine. The registered enrollment target is 17 participants.
The verdict
NCT04374435, a NA study, was terminated before completion, sponsored by University of California, Irvine.
- TERMINATED
- Registry status
- NA
- Development phase
- 17 participants
- Enrollment target
Study Summary
Vitiligo is a dermatologic disease characterized by depigmentation of the skin. While the loss of melanocytes observed in vitiligo is driven by the immune system, repigmentation of the skin that occurs during UV light treatment is driven by melanocytes that migrate out of the hair follicle and into the epidermis or the activation of stem cells within the epidermis. Unfortunately, some skin areas affected by vitiligo have very few hair follicle melanocytes and an indeterminate number of epidermal melanocytes and therefore unable to respond to light therapy. This pilot study seeks to examine the relative efficacy of different harvesting methods for the melanocyte keratinocyte transplant procedure (MKTP) in the treatment of vitiligo. In addition, this study will analyze the tissue of excess tissue harvested during the procedure to identify distinct cellular and molecular features of chronic vitiligo. Patients in Dr. Ganesan's clinic at the UCI (University of California, Irvine) Department of Dermatology will be approached for participation in the study. The study will include both men and women and will not be limited by race or ethnicity. The investigators will exclude individuals less than 18 years old for the study as the investigators believe it would be difficult for these subjects to tolerate the melanocyte keratinocyte transplant procedure. Participants will be offered a melanocyte keratinocyte transplant procedure with one of the three different tissue harvesting methods (a blade, suction blister) and the method without dissociation (Cellutome). This study has three arms: 1. MKTP with Surgical Blade 2. MKTP with Negative Pressure Instrument (suction blistering device). 3. Suction blister grafting without cell dissociation utilizing Cellutome (a device used for treating chronic burn wounds)
Interventions
- PROCEDURE MKTP with Surgical blade
- DEVICE MKTP with Negative Pressure Instrument
- DEVICE Suction blister grafting without cell dissociation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2017-09-29 |
| Est. Completion | 2022-05-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04374435
The ClinicalTrials.gov registry entry for NCT04374435 describes a study currently listed as terminated, categorized as NA. The registered enrollment target is 17 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of California, Irvine, which has 368 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which MKTP with Surgical blade is the first listed.
NCT04374435 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT04374435 about?
NCT04374435 is a clinical study titled "Evaluating the Efficacy of the Melanocyte Keratinocyte Transplantation Procedure in the Treatment of Vitiligo". Vitiligo is a dermatologic disease characterized by depigmentation of the skin. While the loss of melanocytes observed in vitiligo is driven by the immune system, repigmentation of the skin that occurs during UV light treatment is driven by melanocytes that migrate out of the hair follicle and into ...
What is the current status of trial NCT04374435?
This trial is currently terminated. It is a NA study. The enrollment target is 17 participants. The study started on 2017-09-29. Estimated completion is 2022-05-01.
What interventions are being tested in trial NCT04374435?
The interventions under investigation include: MKTP with Surgical blade (PROCEDURE), MKTP with Negative Pressure Instrument (DEVICE), Suction blister grafting without cell dissociation (DEVICE).
Who is sponsoring clinical trial NCT04374435?
This trial is sponsored by University of California, Irvine, which has 368 total clinical trials registered on ClinicalTrials.gov.
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